Biosimilars

A biosimilar is a pharmaceutical product which contains a new version and new properties of the active ingredient of a biological original medicine. Moreover, comparative studies have demonstrated that its efficacy and safety are sufficiently similar to those of the original biological product. When the patent of the biological medicine expires, manufacturers other than the developer of the original medicine can start to make it.

The biological medicines constitute a heterogeneous group where the pharmaceutical substances are of highly different molecular sizes and varying complexity. A biological medicine and its biosimilar are not the same medicine, and a biosimilar cannot be a generic substitute for the original biological medicine or for another biosimilar.

The importance of biological medicines is constantly growing. However, the high prices associated with biological medicines have limited their use in hospitals, also impacting their reimbursement status.

The biosimilars introduced to the market after the expiry of the patent of the original biological medicine will launch a price competition that brings therapy costs down. This may increase the opportunities to introduce novel medicines in hospitals, thereby contributing to their entry into the reimbursement system.